ORAD — Organisme Responsable de l’Accès aux Données de Santé

Overview

ORAD is the French designation for the national health data access body that France is required to establish under the EHDS regulation (Regulation (EU) 2025/327), which entered into force in March 2025. The EHDS requires each EU member state to designate one or more health data access bodies responsible for managing secondary use of electronic health data for research, policy, and public health purposes, including operating a secure processing environment and handling data access requests. Member states have a transition period to formally designate their body and implement the secondary use framework. The Health Data Hub is the primary candidate for this role in France, given its existing mandate as the national health data platform, its operation of a secure Datalab environment, and its experience managing access to the SNDS, though formal designation had not been confirmed as of mid-2025.

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